Safety needle with collapsible sheath

ABSTRACT

The Huber needle is drawn into a protective cap and sheath arrangement after use for disposal purposes. The cap is tethered to a housing in which the needle is mounted by the sheath. The sheath is made of a film material that has a high tensile strength and a low percent of elongation, such as polyester. The sheath is initially mounted about the needle in a collapsed accordion-like condition between the cap and housing. When the cap is moved along the needle, the sheath is played out over the needle. The cap houses a spring clip to snap over the bore through which the needle is retracted to prevent re-emergence of the needle. The flexible nature of the sheath allows the sheath to pass about the two legs of the Huber needle.

This is application claims priority of Provisional Patent Application60/339,786 filed Dec. 17, 2001.

This application is a Division of Ser. No. 10/320,168, filed Dec. 16,2002.

This invention relates to a safety needle with a collapsible sheath.More particularly, this invention relates to a safety needle thatcontains a sharpened edge needle that can be rendered harmless topuncture.

Needle protectors are well known and have been in use for many yearswith needles used with hypodermic syringes. Conventionally, needles aremade with hubs and sockets adapted to be attached to the reduced end ofa syringe. A molded plastic cap is conventionally removably secured tothe hub of the needle. After mounting the needle on the syringe, the capis removed to expose the needle for use.

Accidental needle stick injuries, unfortunately, are still common inhealth care workers, such as nurses, physicians, laboratory workers andhousekeeping personnel. Needle stick exposures can result intransmission of hepatitis B, as well as acquired immune deficiencysyndrome-AIDs, or other transmittable diseases. The health hazardsassociated with needle stick injuries are of greater risk for healthcare workers now than ever before.

Accidental needle sticks often occur when a blood drawer attempts torecap a needle after use or leaves a contaminated needle exposed on worksurfaces where the blood drawer or other workers accidentally impalethemselves.

It is well known that used hypodermic needles are extremely susceptibleto transmitting diseases. Hepatitis and other highly contagious diseasescan be transmitted by successive use of the same needle by differentindividuals. In a hospital environment, however, precautions are takento avoid use of contaminated needles by their expeditious disposal.Problems exist, however, in storing the needle for disposal. Commonly,the protective cap associated with the needle receives the used needlefor discarding. However, it is apparent that the bore of the needle capis dimensioned not much greater than the diameter of the needle and itsneedle base that removably attaches to a syringe. Misalignment of theneedle with respect to the cap when trying to reinsert the needletherein can cause the hand that holds the cap to be punctured, therebyincreasing the likelihood to transmission of a contagious disease.

U.S. Pat. Nos. 2,847,995 and 3,134,380 describe shields that are usedwith hypodermic needles in which the shield or protector is adapted tobe accordioned for use and then expanded to cover the tip of the needle.This type of needle-tip protector is contemplated to be mounted on thesyringe or at least the needle hub and remain in a mounted conditionduring use. With the rapid increase in AIDS-infected and human carriers,there has been a concentration of providing needle protection. U.S. Pat.No. 4,592,744 describes a specially constructed hub and a self-sheathingassembly. Devices similar to this are known to the art and are utilizedto provide a protecting extending flange secured to or as a portion of atubular cap that is to be reinstalled to cover the needle. Shieldedprotectors which anticipate flange extensions are numerous and have beenpromoted and or offered as a protector of the attendant.

Also known are needle tip protectors that anticipate attendantmanipulation. Representative of these manipulated devices are thosedescribed in U.S. Pat. Nos. 2,876,770; 2,925,083 and 3,306,290. U.S.Pat. No. 4,725,267 refers to a corrugated structure having an end capfor enclosing a sharpened needle.

Accordingly, it is an object of this invention to provide a needleassembly with a protective sheath.

It is another object of the invention to reduce the risk of aninadvertent “stick” from a used needle.

It is another object of the invention to maintain a used needle in asealed condition for disposal.

It is another object of this invention to provide a collapsible sheaththat corrugates upon collapsing and extends to a tube construction toprotect a used needle.

It is another object of this invention to provide a unique positive lockto prevent a sharpened end of a needle from exiting a protective sheath.

It is another object of this invention to provide a positive lockingfeature for a cap to be disposed over the sharpened end of a needleprior to actuation.

Briefly, the invention is directed to a combination of a housing; aneedle extending from the housing; a cap concentrically disposed overthe needle and being movable relative to the needle from a firstposition with the needle extending therethrough to a second positionwith an end of the needle disposed therein in sealed relation; and anon-resilient tubular sheath of plastic concentrically disposed on andabout the needle in a collapsed state and secured to and between thehousing and the cap. The sheath is longitudinally extendable from thecollapsed state to an extended state in response to movement of the capfrom the first position to the second position thereof.

In accordance with the invention, the sheath is characterized in being afilm having a high pull force that allows the sheath to be pulled outfrom the collapsed condition to the extended state without breaking.

The sheath is made of two strips of film material, preferably,polyester, with each strip having a sealable backing, such aspolyethylene, thereon facing the other of the strips. The strips arebonded together along two longitudinal edges with the sealable backingsin contact to form a tube with two outwardly directed flanges.

In another embodiment of the invention, the cap is made of rigidconstruction and has a bore for passage of the needle. In addition, ameans is disposed in the cap for selectively sealing off the bore to thepassage of the needle therethrough. Typically, this means is a springclip disposed over the bore of cap. In one case, the clip is of a typehaving a pair of leaves spring-biased onto the needle with the needle inthe first position thereof and closing over the bore with the needle inthe second position thereof. In another case, the clip has a single leafspring-biased onto the needle with the needle in the first positionthereof and closing over the bore with the needle in the second positionthereof.

In this latter embodiment, the sheath is characterized in having a lowpercentage of elongation to break. This characteristic allows the sheathto be pulled out from the collapsed condition and to be slightlystretched to allow the cap to extend beyond the end of the needle inorder to allow the leaf or leaves of the spring clip to slide off theneedle into a bore blocking position. Once the clip covers over thebore, the cap is allowed to retract under the force in the stretchedsheath.

In still another embodiment, the sheath is particularly adapted toprotect a Huber needle after use. In this embodiment, the Huber needle,as is known, has a first leg extending from a housing and a second legextending perpendicularly of the first leg. The cap is disposed over thesecond leg of the needle and has a bore through which the second legextends, for example, for insertion in a subcutaneous medicamentdelivery device. The cap is movable relative to the second leg from afirst position with second leg extending therethrough to a secondposition with an end of the second leg disposed therein in sealedrelation.

In this embodiment, the tubular sheath is concentrically disposed on andabout the needle in a collapsed state and is secured to and between thehousing and the cap. The sheath, as above, is extendable from thecollapsed state to the extended state in response to movement of the capfrom the first position to the second position thereof.

In addition, in accordance with the invention, the cap is mounted on thehousing in the first position thereof and a means is provided forreleaseably locking the cap on the housing. In one case, this meansincludes a recess in one of the housing and the cap and a projection onthe other of the housing and the cap for snap-fitting into the recess.The housing and cap can, thus, be readily handled as a unit to insertthe exposed leg of the Huber needle into a subcutaneous delivery devicein a patient. In addition, the cap can be readily dis-engaged from thehousing when the needle is removed from the patient.

As above, the cap houses a means, such as a spring clip, for selectivelysealing off the bore to the passage of the second leg of the needleafter the needle has been used. Also, as above, the spring clip has aleaf biased onto the second leg of the needle with the cap in the firstposition thereof and closing over the bore with the cap in the secondposition thereof. The leaf also has a rounded end for sliding on the legof the needle without scratching of the needle or obstructing movementof the needle.

In this embodiment, the cap is constructed of a plastic material, as bymolding, with a plurality of walls to define an interior chamber forsealingly receiving the end of the second leg of the needle in thesecond position of the cap. In order to gain access to the chamber aftermolding, for example, to mount the spring clip in place, one of thewalls is molded so as to be movable from a first formed position spacedfrom an other of the walls to allow access to the chamber to a secondposition in sealed relation to this wall to close the chamber. Thespring clip is mounted on this movable wall for movement therewith fromthe molded first position to the second position. In this way, as thechamber is closed, the spring is put into place.

The cap is also constructed to have a pair of flexible wings extendingoutwardly from opposite sides of the cap for engaging a body of apatient. A soft pad may also be secured to an underside of each wing.

In any of the above embodiments, when the needle is to be removed from apatient or from a subcutaneous device within the patient, the cap isdisconnected from the housing and slid along the needle. As the needleis then withdrawn from the patient, the needle enters directly into thecap. During this time, the sheath extends from the collapsed storedposition into the extended position. Where a leaf spring is employedwithin the cap to close over the bore through which the needle isretracted, the cap is pulled beyond the needle thereby stretching thesheath without breaking the sheath until the spring snaps into ablocking position over the bore. The cap is then released so that thesheath retracts slightly into an untensioned state.

The cap covers over the free end of the needle to avoid inadvertent“sticks” from occurring. Further, since the sheath and cap completelyenvelop the needle, the needle is maintained in a closed sterilecondition. Also, any fluids that might be withdrawn with the needle arecontained within the sheath and cap. This presupposes that the housingis also closed to prevent a back flow from the needle.

In the case where the sheath is used over a Huber needle, thenon-resilient nature of the sheath allows the sheath to be extended froma collapsed position into an extended L-shaped configuration over theHuber needle.

Since the cap is releasably connected to the housing, the cap andhousing can be manipulated as a unit in order to implant the exposed endof the Huber needle in a sub-cutaneous device, such as an infusion port,in a patient. When the needle is to be withdrawn, the cap is heldagainst the patient while the housing is pulled away from the cap.Employing the wings on the cap allows the attendant to keep a firm gripon the cap while the needle is drawn through the cap and the free end ofthe needle placed within the closed chamber of the cap.

These and other advantages will become more apparent from the followingdescription taken in conjunction with the accompanying drawings wherein:

FIG. 1 illustrates a side view of a syringe assembly constructed inaccordance with the invention with a needle in an unprotected positionand ready for use;

FIG. 2 illustrates the syringe assembly of FIG. 1 in partial crosssection with the slider containing the locking mechanism partiallyextended along the shank of the needle;

FIG. 3 illustrates the syringe assembly of FIG. 1 in partial crosssection with the cap fully extended and enclosing the sharpened point ofthe needle;

FIG. 4 illustrates sheets of polyester film having a sealable materialon one side and cut to size prior to forming;

FIG. 5 illustrates the cap adaptor which is attached to one end of theformed film sheath;

FIG. 6 illustrates the housing adaptor which is attached to the secondend of the formed sheath;

FIG. 7 illustrates the housing adaptor and cap adaptor positionedbetween the two sheets of sealable polyester film with the sealablesides interfacing with each other and the two adaptors;

FIG. 8 illustrates in partial cross section the polyester film sealed toitself with a scalloped edge, with a central unsealed tubular sectionand sealed at the ends to the two adaptors;

FIG. 9 illustrates the “H” clip with the two leaves partially opened;

FIG. 10 illustrates a side view of the “H” clip showing the leaves in arest condition;

FIG. II illustrates in cross section the cap as molded of plastic withopenings for the needle and cap adaptor detents;

FIG. 12 illustrates in partial cross section the cap and cap adaptorpreviously sealed to the polyester film in place and “H” clip positionedin the distal end of the cap;

FIG. 13 illustrates in partial cross section the needle positionedwithin the housing with provision for accepting the housing adaptordetents;

FIG. 14 illustrates in cross section the housing adaptor locked withinthe needle holder housing and attached plastic film collapsed therein;

FIG. 15 illustrates in partial cross section the “H” clip secured inplace by the cap adaptor extension;

FIG. 16 illustrates in partial cross section the “H” clip retractedafter the needle is moved into the cap;

FIG. 17 illustrates the cap adaptor, housing adaptor and sealed film asan assembly unit prior to placement in the housing and cap;

FIG. 18 illustrates another embodiment of the invention in partial crosssection in which the corrugated sheath is formed in the shape of aconical shaped tube with fins;

FIG. 19 illustrates a cross sectional view of a syringe assemblyemploying a sheath in accordance with the invention;

FIG. 20 illustrates a position of a leaf spring within the cap of thesyringe assembly of FIG. 19 in a blocking position;

FIG. 21 illustrates a view similar to FIG. 20 to indicate the manner inwhich the spring clip prevents re-emergence of the needle through thecap;

FIG. 22 illustrates a perspective view of the spring of FIGS. 19-21;

FIG. 23 illustrates a perspective view of a modified spring inaccordance with the invention;

FIG. 24 illustrates a view similar to FIG. 19 of a modified syringeassembly constructed in accordance with the invention;

FIG. 25 illustrates a partial view of a syringe assembly employing anintroducer needle and a guide wire in accordance with the invention;

FIG. 26 illustrates a view similar to FIG. 25 with the introducer needleretracted;

FIG. 27 illustrate a view similar to FIGS. 25 and 26 with the introducerneedle and guide wire retracted within the cap;

FIG. 28 illustrates a top view of the syringe assembly of FIG. 19;

FIG. 29 illustrates a view of the syringe assembly of FIG. 28 with thecap in a partially extended state;

FIG. 30 illustrates the syringe assembly of FIG. 28 with the cap in afully extended position;

FIG. 31 illustrates a view of a biopsy needle assembly constructed inaccordance with the invention;

FIG. 32 illustrates a Huber needle constructed in accordance with theinvention;

FIG. 33 illustrates a view of the needle of FIG. 32 with a cap and apartially extended state;

FIG. 34 illustrates a view of the needle of FIG. 32 with the cap in afully extended position;

FIG. 35 illustrates a cross sectional view corresponding to FIG. 32;

FIG. 36 illustrates a cross sectional view of the components of theneedle of FIG. 35;

FIG. 37 illustrates a cross sectional view of the component's of theneedle of FIG. 35’

FIG. 38 illustrates a enlarged view of a connection of the Huber needlein the housing of the needle assembly of FIG. 32;

FIG. 39 illustrates a cross sectional view of a snap fit connection ofthe cap and housing of the Huber assembly of FIG. 32;

FIG. 40 illustrates a cross sectional view of the cap of the assembly ofFIG. 37 prior to final assembly;

Fig. illustrates a side view of a modified Huber needle assembly withaccordance with the invention;

FIG. 42 illustrates a top view of the Huber needle assembly of FIG. 40;

FIG. 43 illustrates a manner of inserting a Huber needle assembly ofFIG. 40 in a patient; and

FIG. 44 illustrates a view of the Huber needle assembly of FIG. 32during removal from an infusion port in a patient;

Referring to FIG. 1, the syringe assembly 10 includes a stainless stealneedle 11 having a sharpened end 21 that is mounted in a housing 13 in aconventional manner. In addition, the assembly 10 includes a cap 12 thatis concentrically disposed over the needle 11 to be moveable relative tothe needle from a first position as indicated in FIG. 1 with the needleextending there through to a second position as indicated in FIG. 3 withan end of the needle 11 disposed therein and sealed relation. Inaddition, as indicated in FIGS. 2 and 3, a non-resilient tubular sheath22 is concentrically disposed on an about the needle 11 and is securedto and between the housing 13 and cap 12. The sheath 22 islongitudinally extendable from a collapsed state (not shown in FIG. 1)to an extended state as indicated in FIG. 3 in response to movement ofthe cap 12 from the first position to the second position thereof.

Both the cap 12 and housing 13 are made of suitable materials, such as aplastic, and each is of rigid construction. In addition, means isprovided for selectively locking the cap 12 on the housing 13. Asindicated in FIGS. 1 and 2, this means is formed as a bayonet-type lock.That is to say, the housing 13 is provided with a pair of oppositelydisposed L-shaped slots 19 (only one of which is shown) in an end of thehousing 13 while a pair of pins 18 are formed integral with the cap 12for sliding within each respective slot 19. Upon assembly, the pin 18 isslid into the slot 19 through the short leg, as viewed, and rotated intothe long leg, as shown, to achieve a positive lock.

The proximal portion of the housing 14 includes a female luer hub 14having a sealing thread 15 for connection to a syringe, extension set orthe like (not shown).

When used, after the needle 11 has been inserted into a patient forwhatever reason and is to be withdrawn, the cap 12 is rotated relativeto the housing 13 so as to align the pins 18 with the respective shortlegs of the respective slots 19. There after, the cap 12 is movedmanually along the length of the needle 11 to a point where the needleemerges from the body of the patent. As indicated in FIG. 2, as the cap12 moves away from the housing 13, the sheath 22 begins to play-out fromthe housing 13. As the needle 11 emerges from the body of the patent,the needle 11 moves directly into the cap 12. At this time, as indicatedin FIG. 3, the sheath 22 is fully extended.

The sheath 22 is characterized in having a high tensile strength thatallows the sheath 22 to be pulled out from the collapsed condition ofFIG. 1 to the extended state of Fig. without breaking.

Referring to FIG. 4, the sheath is made of two strips 23 of filmmaterial. Each strip 23 is made, preferably, of a polyester, such asMylar, with a co-extruded sealable backing 23′ of a polyethylene, suchas Surlyn, facing the other of the strips 23. The strips 23 are bondedtogether along two longitudinal edges with the sealable backings 23′ incontact to form a tube with two outwardly directed flanges. The stripsare characterised in being made of 92 ga. Mylar LB having an ultimatetensile strength of, at a minimum, 27 psi as tested in accordance withASTM D882 and an ultimate elongation of, at most, 80% in accordance withASTM D882.

The polyester film may be 0.5 to 1.0 mil thick while the backing 23′maybe a polyethylene film of from 0.5 to 2.0 mils thick. Alternatively,a commercially available adhesive maybe used as a backing.

Referring to FIGS. 5 and 7, in order to mount the sheath 22 in thesyringe assembly of FIG. 1, one end of the sheath 22 is secured to a capadapter 24 while the other end is secured to a housing adapter 25.

The strips of film 23 are of unitary construction and are sealedtogether using suitable ultrasonic sealing techniques. For example, thetwo sheets 23 may be placed in a die having the desired configurationwith the sealing surfaces facing one another. The adapters 24, 25 areplaced at opposite ends of the die and positioned between the twosealable portions 23 of the strips 23. A suitable cutting/sealing die isthen used to seal the two films together including sealing the adapters24, 25 to the films 23. The cutting die which normally is an integralpart of the process may scallop the edges of the film as indicated inFIG. 3 or cut the film tubular geometry as indicated in FIG. 18. Ineither event, the interior wall of the sheath 22 has a smallerequivalent diameter at the distal and 35 and a larger equivalentdiameter 36 at the proximal end.

Depending upon the angle which these two diameters 35, 36 create for agiven film thickness, the result called the “compression ratio”determines the length the formed sheath 22 can be expanded for a giveninitial compressed length. For example, for a 0.5 mil polyester filmhaving a 1.5 mil backing of polyethylene and initial equivalent diameterof 0.045 inch and 0.060 inch, a 1.0 inch length of compressed sheath 22will expand to 7 inches in free length. This property provides for asubstantial free length with only a minimum amount of storage length.Compression ratios at relatively low variances between equivalentdiameters at the distal and proximal ends result in “compression ratios”of 10 to 15. An important feature is that the sheath 22 has a smallouter diameter with a compression ratio of 10 or more. The result is alow profile compact sheath which can be extended to significant lengthsand that exhibits a high tensile strength. For example, a sheath 22 madeof 1.0 mil polyester films 23 with an apparent diameter of 0.050 incheshas a breaking force of 17 pounds.

Referring to FIGS. 5 and 7, the cap adapter 24 has a hollow tubularprojection 65 for sealing to the sheath 22. In addition, the cap adapter24 has a pair of outwardly directed detents 27 and a pair oflongitudinal extensions 29 for purposes as described below.

Referring to FIGS. 6 and 7, the housing adapter 25 has a hollow tubularprojection 66 for securement to the sheath 22 as well as outwardlydirected spring detents 28 for purposes as explained below.

Referring to FIG. 11, the cap 12 is made of molded plastic and has apair of side apertures 34 on opposite sides for receiving the detents 27of the cap adapter 24 as indicated in FIG. 12. The cap 12 also has acentral hub with a central bore 33 to allow passage of a needle 11 (seeFIG. 1).

Referring to FIG. 12, a means in the form of a spring clip 26 isdisposed within the cap 12 and is fitted within a central bore 46 of thecap 12 against a vertical wall 47 as indicated in FIGS. 9 and 10. Theclip 26 is in the form of an “H” clip having a pair of spring-biasedleaves 31 directed outwardly of a central opening.

Referring to FIG. 12, the cap adapter 24 is fitted into the cap 12 sothat the detents 27 of the adapter 24 snap into the apertures 34 thecap. At the same time, the extensions 29 on the end of the adapter 24abut against the spring clip 26 to retain the clip 26 in place. Theposition of the detents 27 as related to the position of the pins 18 sothat when the detents 27 snap into place, the pins 18 are orientedrelative to the slots 19 in the housing 13 (see FIG. 1).

The spring clip 26 is preferably made of stainless steel with athickness of 5 mils and an H configuration is punched out of the clip sothat the two leaves 31 have a small opening therebetween. This openingis sufficient to reduce the frictional resistance on a needle 11positioned between the leaves so that the cap 12 is able to move freelyover the needle 11. Upon retraction of the needle 11 into the cap 12,the leaves 31 close to the position indicated in FIG. 10. This closureis sufficient to prevent the sharp point 21 of the needle 11 frompenetrating the clip 26 thereby preventing the needle 11 fromre-emerging from the cap 12.

The sheath 22 is characterized in having low percentage of elongation tobreak, for example, no more than 80 percent. This characteristic allowsthe sheath 22 to be pulled out from the collapsed condition of FIG. 1and to be slightly stretched to allow the cap 12 to extend beyond theend 21 of the needle 11 in order to allow the leaves 31 of the springclip 26 to slide off the needle 11 into a bore locking position. Oncethe clip leaves 31 cover over the bore 33, the cap 12 is allowed toretract under the force of the stretched sheet 22. With the needle point21 within the cap 12 and beyond the clip 26, further movement of the cap12 either proximally or distally is prevented. The sharp tip 21 of theneedle 11 is thus trapped within the cap 12. The safety needle may nowbe safely discarded.

Referring to FIG. 13, the needle 11 is fitted into a bore 61 of thehousing 13 and secured in place by a suitable adhesive 62. The needle 11is aligned with a tapered bore 16 of the female luer lock hub 14 thatprovides a means for attaching the housing 13 to a male luer adapter(not shown) to secure a connection, for example, to a syringe.

The housing 13 also has a central opening 63 for receiving the housingadapter 25 of the cap 12 as indicated in FIG. 14. To this end, a pair ofopenings 64 are provided in the housing 13 in order to receive detents28 of the housing adapter 25 as indicated in FIG. 14.

Referring to FIG. 14, when the cap 12 (not shown) is mounted on thehousing 13, the housing adapter 25 is forced under pressure into thecentral opening 63 of the housing 13 until the detents 28 which compressslightly during movement through the central opening 63 are aligned withthe openings 64. At this point, the detents 28 expand to fill theopenings 64. A lock between the housing 13 and housing adapter 25 isthus achieved thereby securing the attached sheath 22 to the housing 13via the adapter 25. As illustrated, the sheath 22 is disposed in acompressed or corrugated condition within the central opening 63. Theneedle 11 is omitted from FIG. 14 for purposes of clarity.

Referring to FIG. 15, when the cap 12 is mounted in place, the needle 11passes through the spring clip 26 with the leaves flexed outwardly inorder to slide along the needle 11 when the cap 12 is to be extended.

Referring to FIG. 16, when the cap 12 is extended beyond the sharpenedend of the needle, the leaves of the spring clip 26 flex inwardlythereby blocking the bore 33 to prevent re-emergence of the needlethrough the bore 33.

Referring to FIG. 17, the adapters 24, 25 and sheath 22 form an assemblythat can be handled as a unit. In the condition illustrated, the tubularextensions 65, 66 of the adapters 24, 25 are abutted together and thesheath 22 is collapsed within the space between the adapters 24, 25.This assembly is placed over the needle 11 and slid into the housing 13for securement in place as indicated in FIG. 14. At this time, the cap12 is aligned with the needle 11. A blunt cannula (not shown) is thenplaced through the cap 12 from the distal position and the clip 26 ismoved over the blunt cannula to open up the leaves 26. The needle 11 isthen placed within the blunt cannula which is now removed so that theneedle 11 is now within the clip 26 and the cap 12 can now be movedalong the needle 11 towards the housing 13. The cap 12 is moved alongthe needle 11 until contacting the adapter extensions 29 which tend toalign the clip 26 perpendicular to the axis of the needle 11. The cap 12is then forced into the housing 13 so that the detents 27, 28 previouslyoriented during formation of the sheath 22 are compressed. When therespective detents 27, 28 snap into the respective openings 34, 64, theadapters 24, 25 are locked within the respective cap 12 and housing 13.At the same time, the pins 18 of the cap 12 enter into the recesses 19of the housing 13. A turning of the cap 12, for example counterclockwiseapproximately 45 degrees secures the cap 12 within the housing 13.

In use, the cap (not shown) which ordinarily protects the sharpened end21 of the needle 11 from damage during storage is removed therebyexposing the assembly as shown in FIG. 1. This assembly may or may notbe attached to a syringe, guide wire or the like part to use. The needle11 now penetrates a patient's skin and normally interdicts a bloodvessel. After infusion, guide wire placement, or the like, the needlemay be withdrawn from the patient. In one instruction for use, the cap12 at that time is rotated counterclockwise to release the cap 12 fromthe housing 17. The cap 12 is then moved to an extended position and asthe needle is removed from the patient, the cap 12 entraps the sharp end21 of the needle. In this position, the assembly may be disposed ofwithout concern for a needle stick.

Referring to FIG. 18, wherein like reference characters indicate likeparts as above, the sheath 41 may be formed in a tapered or conicalshape with tapered or conical outer and inner walls 42, 43.

Referring to FIG. 19, the syringe assembly 70 includes a housing 71having a female luer hub 72 at one end that defines a flash chamber 73.As above, a needle 74 with a sharp end 75 is mounted in the housing 71in fixed manner to communicate with the flash chamber 73.

The syringe assembly 70 also has a cap 76 slidably mounted on thehousing 71. In this embodiment, the cap 76 has a head 77 concentricallydisposed over the needle 74 and an elongated sleeve 78 that extends fromthe head 77 over the housing 71. The head 77 and sleeve 78 are securedtogether in any suitable manner, such as by bonding or ultrasonicwelding.

As shown, the sleeve 78 abuts against an annular flange 79 on thehousing 71 so as to be located in a retracted position.

The housing 71 has a tubular extension 80 on which one end of a sheath81 of a material as described above is mounted in concentric manner. Asindicated, a suitable adhesive 82 is provided to sealingly secure theend of the sheath 81 to the housing 71 about the tubular extension 80.

The opposite end of the sheath 81 is mounted on a tubular extension 83of the head 77 by means of a suitable adhesive or other suitable sealingtechnique. This head 77 is sized to be slidably received within thesleeve 78. In addition, the head 77 has a radially outwardly directedpost 85 over which a spring clip 86 is mounted.

As indicated in FIG. 22, the spring clip 86 has a bore 86′ for passageof the post 85 and is of L-shape with a leaf having a rounded end 87 forresting against the needle 74 as indicated if FIG. 19.

The head 77 has a central bore 88 through which the needle 74 passes. Inaddition, the leaf of the spring clip 86 is sized to lay over the bore88 in order to prevent re-emergence of the needle 74 therethrough asdescribed below.

Referring to FIG. 23, the spring clip 86 a may be formed without arounded end as indicated and with a bore 86 a′.

In order to assemble the syringe assembly 70, the sheath 81 is mountedon the tubular extension 83 of the head 77. The spring clip 86 is thenmounted on the post 85 located on the head 77. The head 77 is theninserted into the sleeve 78 and bonded in place.

Next, the needle 74 is inserted into the head 77 through the centralbore 88 and through the sheath 81 into the housing 71. The needle 74 isthen bonded or otherwise secured to the housing 71.

Thereafter, the sheath 81 is bonded to the extension 80 of the housing71.

The sleeve 78 is then slid onto the housing 71 into abutment with theannular flange 79. As indicated in FIG. 30, the housing 71 is providedwith a post 90 to be fitted into an L-shaped slot 91 in the cap 76 toform a bayonet connection to secure the cap 76 to the housing 71.

In use, when the needle 74 is being withdrawn from a patient, the cap 76is slid off the housing 71 and moved over the needle 74. As the sharpend 75 of the needle is withdrawn from the patient, the cap 76 is movedbeyond the end 75 of the needle as indicated in FIG. 20 wherein likereference characters indicate like parts as above. At this time, theleaf of the spring clip 86 snaps forwardly to cover over the bore 88 inthe head 77.

Referring to FIG. 21, should the needle 74 be moved forward, the springclip 86 prevents re-emergence of the needle 74 through the bore 88 ofthe head 77 of the cap 76.

Referring to FIG. 24, wherein like reference characters indicate likeparts as above, the head 77 may be modified to have an elongated tubularprojection 83′ to allow the needle 74 to move forward and to retractwithout contacting the sheath 81 and thereby avoid any friction contactof the needle 74 with the sheath 81.

Referring FIGS. 25, 26 and 27, wherein like reference charactersindicate like parts as above, the needle 74′ may be an introducer needlewhich cooperates with a guide wire 89 (see FIG. 26). In this embodiment,the introducer needle 74 is first retracted from a patient from aposition indicated in FIG. 25 to the position indicated in FIG. 26.Thereafter, the guide wire 89 is retracted from the patient and movedinto the cap 76 a sufficient extent to permit the leaf spring 85 to snapback over the bore 88 as indicated in FIG. 27 thereby blockingre-emergence of the introducer needle 74′ or guide wire 89.

Referring to FIGS. 28, 29 and 30 wherein like reference charactersindicate like parts as above, the cap 76 may be mounted on the housing71 using a bayonet lock connection similar to that as described above.In this embodiment, the housing 71 is provided with a pair of posts 90(only one of which is shown) while the sleeve 78 of the cap has a pairof L-shaped groves 91 each of which is positioned to receive a post 90of the housing 71. In order to release the cap 76, the cap 76 is rotatedfrom the position shown in FIG. 28 to the position shown in FIG. 29 andpulled axially from the housing 71. The cap 76 is then extended to thefully extended position of the sheath 81 (FIG. 30) so as to close overthe end 75 of the needle 74.

Referring to FIG. 31, wherein like reference characters indicate likeparts as above, the needle assembly may be constructed as a biopsyneedle. In this case, the housing 71′ is constructed in a conventionalmanner and need not be further described.

Referring to FIGS. 32, 33 and 34, wherein like reference charactersindicate like parts as above, the sheath 22 is particularly useful for aHuber needle 92. In this embodiment, the sheath 22 extends between ahousing 93 and a cap 94.

Referring to FIG. 35, the Huber needle 92 is of L-shaped constructionand has a proximal leg secured in a fixed manner within the housing 93.The second leg of the needle 92 extends through the cap 94.

The cap 94 is of generally block construction and is slideable along theleg of the needle 92 from a position as indicated in FIG. 32 to aposition as indicated in FIG. 34. The cap 94 includes a bore 95 forpassage of the needle 92 and is moveable from the position shown in FIG.35 to the position shown in FIG. 37. The cap 94 includes a tubularextension 96 on which the sheath 22 is secured in a manner as describedabove. Likewise, as shown in FIGS. 35 and 38, the opposite end of thesheath 22 is secured to a tubular bushing 97 (e.g. of polyvinylchloride)that extends from a line 98 (e.g. of polyvinylchloride) mounted in thehousing 93. As indicated, the tubular bushing 97 mounts the needle 92and communicates the needle 92 with the line 98. As indicated in FIG.32, a clip 99 may be disposed on the line 98 in order to control a flowof fluid therethrough.

Referring to FIGS. 35 and 39, the cap 94 and housing 93 are constructedso that the cap 94 is fitted into the housing 93 in a snap-fit manner tobe handled as a unit. To this end, the housing 93 has a recess 100 whilethe cap 94 has an extension 101 that fits into the recess 100. Inaddition, as indicated in FIG. 39, a small shoulder 102 is provided atthe mouth of the recess 100 of the housing 93 while the extension 101 ofthe cap has a small recess 103 to receive the projection 102. In thisrespect, when the extension 101 of the cap 94 is fitted into the recess100 of the housing 93, the extension 101 snaps past the projection 102and is thus held in place in a snap fit manner. In order to disconnectthe cap 94 from the housing 93, the housing 93 and the cap 94 are eachmanually grasped and moved apart.

Referring to FIG. 40, the cap 94 is made of a plastic material and isinitially molded with a plurality of walls 104, 105, 106, 107 to definea chamber 108. As indicated, one of the walls 107 is movable from afirst formed position spaced from the bottom wall 108 to a secondperpendicular position in sealed relation to the bottom wall 104 inorder to close the chamber 108. In this respect, the movable wall 107has a reduced end 107′ that is able to snap into a slot 109 in the fixedbottom wall 104.

As shown in FIG. 40, the movable wall 107 carries a spring clip 110 thatis sized to extend over the bore 95 in the bottom wall 104 when themovable wall 107 is brought into a closed position (FIG. 37).

Allowing the wall 107 to be moved permits mounting of the spring clip110 in place in an otherwise closed chamber 108.

Referring to FIG. 37, the cap 94 is provided with a pair of tracks(grooves) 111 on opposite sides to receive corresponding rails (notshown) or projecting ears (not shown) of the housing 93.

Referring to FIGS. 41 and 42, wherein like reference characters indicatelike parts as above, the cap 94 maybe formed as a slender body in orderto slide between two ears 112 of the housing 93. In addition, thealignment tracks 111′ may be placed in the ears 112 while thecooperating rails 113 are placed on the cap 94. In addition, theunderside of the cap 94 is provided with a pair of outwardly directedwings 114 of flexible material and the underside of the housing 93 isprovided with a pair of outwardly directed wings 115.

In order to use the Huber needle assembly, the housing 93 and cap 94 aremanipulated as indicated in FIG. 43 so that the exposed end of theneedle 92 is able to pierce through the sub-cutaneous tissue 116 of apatient into a medicament delivery device, such as an infusion port 117,below the tissue 116. The cap 94 is particularly useful in allowingfinger pressure to be applied to push the needle 92 into the port 117.

Referring to FIG. 44, when it is desired to remove the Huber needle 92,the wings 114 on the cap 94 which lay against the tissue 116 are pressedagainst the patient to hold the cap 94 in place. Thereafter, the housing93 is lifted way from the cap 94 thereby pulling the needle 92 out ofthe infusion port 117 and out of the patient. During this time, thesheath 22 is extended from the collapsed state to the extended state.

Due to the flexible nature of the sheath 22, the sheath 22 is readilypulled out of the housing 93 as indicated in FIG. 36 and extended intothe fully extended state as indicated in FIGS. 37 and 44 without tearingor impeding movement of the housing 93 away from the cap 94. Once theneedle 92 has moved into the position indicated in FIG. 37 the springclip 110 snaps over the bore 95 in the cap 94 to prevent reemergence ofthe needle 92. Further, since the chamber 108 within the cap 94 isclosed, the end of the needle 92 is maintained in a sealed closedsterile manner. As this time, the Huber needle assembly may be discardedwith the needle 92 contained in a protective manner.

The invention thus provides a simple construction for entrapping aneedle after use in order to protect against inadvertent “sticks”. Theuse of a flexible tubular sheath to encase the needle along with the capthat is attached to the sheath allows the sharp end of various types ofneedle to be trapped within a sealed chamber. Where the sheath is madeof a transparent material, the encased needle may be readily seen todetermine if the needle is broken or not.

Further, the invention provides a relatively simple structure that canbe used to entrap the sharp end of a Huber needle after use.

The invention also provides a positive locking feature for a cap to bedisposed over the sharpened end of a needle prior to actuation as wellas a unique positive lock to prevent a sharpened end of a needle fromexiting a protective sheath.

1. In combination, a housing; a Huber needle having a first legextending from said housing and a second leg extending perpendicularlyof said first leg; a cap disposed over said second leg of said needleand having a bore for passage of said second leg therethrough, said capbeing movable relative to said second leg of said needle from a firstposition with said needle extending therethrough to a second positionwith an end of said needle disposed therein in sealed relation; and atubular sheath concentrically disposed on and about said needle in acollapsed state and secured to and between said housing and said cap,said sheath being extendable from said collapsed state to an extendedstate in response to movement of said cap from said first position tosaid second position thereof.
 2. The combination as set forth in claim 1wherein cap is mounted on said housing in said first position thereof.3. The combination as set forth in claim 2 further comprising means forreleaseably locking said cap on said housing.
 4. The combination as setforth in claim 3 wherein said means includes a recess in one of saidhousing and said cap and a projection on the other of said housing andsaid cap for snap-fitting into said recess.
 5. The combination as setforth in claim 1 further comprising means in said cap for selectivelysealing off said bore to the passage of said second leg of said needletherethrough.
 6. The combination as set forth in claim 5 wherein saidmeans is a spring clip having a leaf spring-biased onto said second legof said needle with said cap in said first position thereof and closingover said bore with said cap in said second position thereof.
 7. Thecombination as set forth in claim 5 wherein said leaf has a rounded endfor sliding of said second leg of said needle therein with said capmoving from said first position to said second position thereof.
 8. Thecombination as set forth in claim 5 wherein said cap has a plurality ofwalls defining an interior chamber for sealingly receiving said end ofsaid second leg of said needle in said second position of said cap. 9.The combination as set forth in claim 8 wherein one of said walls ismovable from a first formed position spaced from an other of said wallsto allow access to said chamber to a second position in sealed relationto said other of said walls to close said chamber.
 10. The combinationas set forth in claim 1 wherein said cap has a pair of flexible wingsextending outwardly from opposite sides thereof for engaging a body of apatient.
 11. The combination as set forth in claim 10 further comprisinga soft pad secured to an underside of each said wing.
 12. Thecombination as set forth in claim 1 wherein said sheath is made of twostrips of film material, each said strip having a co-extruded sealablebacking thereon facing the other of said strips, said strips beingbonded together along two longitudinal edges thereof.
 13. Thecombination as set forth in claim 12 wherein each said strip is made ofa polyester and each said backing is made of polyethylene.
 14. Thecombination as set forth in claim 13 wherein said sheath ischaracterized in having a low percentage of elongation to break and ahigh tensile strength.
 15. The combination as set forth in claim 14wherein said sheath has a percentage of elongation of at most 80%. 16.The combination as set forth in claim 14 wherein said sheath has atensile strength of at least 27 psi.
 17. The combination as set forth inclaim 12 wherein said needle end abuts said cap with said sheath in saidstretched condition.
 18. A cap for receiving an end of a needle, saidcap comprising a plurality of walls defining an interior chamber, a pairof said walls each having a bore therein for passage of a needletherethrough, for receiving an end of a needle, and a third of saidwalls being movable from a first formed position spaced from an other ofsaid walls to allow access to said chamber to a second position insealed relation to said other of said walls to close said chamber toseal the end of the needle therein.
 19. A cap as set forth in claim 18further comprising a spring clip mounted on said third wall for movementtherewith from said first position to said second position thereof, saidclip having a leaf closing over said bore of one of said pair of saidwalls with said third wall in said second position thereof.
 20. A cap asset forth in claim 19 wherein said leaf has a rounded end for sliding ofa needle thereon.
 21. A cap as set forth in claim 18 further comprisinga pair of flexible wings extending outwardly from opposite sides thereoffor engaging a body of a patient.
 22. A cap as set forth in claim 21further comprising a soft pad secured to an underside of each said wing.